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nrT 2 1 2010DEPARTMENT OF THE ARMY MADIGAN ARMY MEDICAL CENTER TACOMA, WASHINGTON 98431·1100 DNfV]S

October 19, 2010

u.s. Nuclear Regulatory Commission, Region IV Nuclear Materials Licensing Branch 612 Lamar Boulevard, Suite 400 Arlington, Texas 76011-4125

Dear Sir or Madam:

This is to inform you that Dr. Jess Graham and Dr. Brent Tinnel meet the requirements of 10 CFR 35.13 (b) and have been approved by the Madigan Army Medical Center (MAMC) Radiation Control Committee (RCC) to begin using radioactive material. We are also requesting to add 1-125

.sealed sources for manual brachytherapy.

Dr. Jess Graham meets the requirements of 10 CFR 35.13 (b)(4)(i) as follows

Licensee State License Number Type ofUse Sky Ridge Medical Center Colorado Colo. 1053-01 100,200,300 Centura Health -:- Littleton Adventist Hospital Colorado Colo. 765-01 100,200,300 Centura Health - Porter Adventist Hospital Colorado Colo. 210-01 100,200,300 Rocky Mountain Cancer Centers of Colorado Colorado Colo. 1012-01 100,200

He also meets the requirements of 10 CFR 35.13 (b)(4)(ii) as follows

Licensee State License Number Permit Number Type of Use Brooke Army Medical Center NRC 42-01368-01 NM-JG-1 100,200,300,500

Dr. Brent Tinnel meets the requirements of35.13 (b)(l) as follows

• He is certified by the American Board ofRadiology in Radiation Oncology

• His certification is dated 05 June 2007 and is designated as "AU Eligible"

He also meets the requirements of 10 CFR 35.13 (b)(4)(ii) as follows

Licensee State License Number Permit Number Type of Use Walter Reed Army Medical Center NRC 08-01738-02 N/A 400

Enclosed you will find the documents required by 10 CFR 35.14 (a).

Request that NRC License 46-02645-03 be amended with the following changes:

• Add Dr. Jess Graham as an Authorized User under 10 CFR 35.100, 35.200, and 35.300, Items 6.E thru 6.KK as outlined on our current license.

• Add Dr. Brent Tinnel as an Authorized User under 10 CFR 35.400 as outlined on our current license.

• Remove Dr. Antonio G. Balingit as an Authorized User as he is no longer assigned to MAMC.

Printed 0$ Recycled Paper

57378 1

We also request that the renewal application (Docket: 030-03368; License: 46-02645-03; Control: 573618) for NRC License 46-02645-03 be amended with the following changes:

• Add Dr. Jess Graham as an Authorized User under 10 CFR 35.100,35.200,35.300, and Items 6.H thru 6.00 as outlined on the license renewal.

• Add Dr. Brent Tinne1 as an Authorized User ofItems 6.D through 6.F and Item PP. as outlined on the license renewal and this ammendment.

• Remove Dr. Antonio G. Ba1ingit as an Authorized User as he is no longer assigned to MAMC.

• Please add the following line to Item 5

Item 5. Radioactive Material Byproduct, Source, and/or Special Nuclear Material

Chemical and/or Physical Form Maximum Amount that May Be Possessed at Any OneTime

PP. 1-125 (specific manual brachytherapy source, 35.400 use)

Sealed source or device (Amersham, Model 6700 series; Bard Brachytherapy, Inc., Model STM 1251; Best Medical International, Inc., Model 2301; Theragenics Corporation, Model 125.506; Nucletron, Model 130.002)

Not to exceed 0.5 millicuries per source and 200 millicuries total

• Please change the following in Item 6

Item 6. Purposes for Which Licensed Material will be used D. through F. and PP. Any manual brachytherapy use permitted by 10 CFR 35.400.

Point of contact for this action is Major Joshua Sperry, Radiation Safety Officer, commercial phone (253) 968-4300.

Sincerely,

A;mM.sMajor, US Army Chief, Health Physics nd Radiation Safety Office

Enclosure 1. American Board of Nuclear Medicine Certification, Preceptor Statement, and workload for

Dr. Jess Graham 2. Licenses listing Dr. Jess Graham as an Authorized User (5) 3. American Board ofRadiology Certification and Preceptor Statement for Dr. Brent Tinnel 4. Letter from WRAMC approving Dr. Brent Tinnel as an Authorized User for NRC License

08-01738-02

Enclosure 1

American Board of Nuclear Medicine Certification, Preceptor Statement, and workload for Dr. Jess

Graham

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. 1. Name at InRlvll:fual, prapoliPd Authorizailcn (e.g., Radlatlcn Safety Officer), and Appll~abla TraininG Requirements

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6. Tha trqlnln9 and BxpariencQ Indicated above waD obtained 7. PRECEPTOR APPROVALunder the'l~peLY.I!!.~'1 of: ' ___. • ...1 •

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Enclosure 2

Licenses listing Dr. Jess Graham as an Authorized User (S)

• Sky Ridge Medical Center

• Centura Health - Littleton Adventist Hospital

• Centura Health - Porter Adventist Hospital

• Rocky Mountain Cancer Centers of Colorado

• Brooke Army Medical Center

STATE OF COLORADO Bill RilI,r, Jr.• Gowmor

~. Jam.. e. Matlin. Ex,r:utlv, Di~r

Cedlce1ad to prou:eting and improving !he health and envlronmen1 ot the paopla ot COlorado

4300 Cheny Creek Dr. $. L.abotatory SeNten lJillillion 0.'11191, OoloradCl802*1~ 8100 Lowry Blvd. Phcno (303) 182-2000 atn....', Co'~ado aoa30-69ae TOD Line (303) sg1·noo (303) e92-30~ Located In Gleodllle, ColorllOo

htIp:Ilwww.cclphe.lItll.••co.us

Sky Ridge Medical Center 10101 RidgeGate Parkway Lone Tree, Colorado 80124 SEP .. 9 ZaD9

Attention: Daniel W. Marvel, M.S., Radiation Safety Officer

Rc: License Amendment Colorado Radioactive Materials License Number Colo. 1053-01

Enclosed is Radioactive Materials Ucense Number Colo. 1053·01, Amendment No. 14. The license has been amendcd as rcqucstcd in a correspondence from Karen Yowell dated August 10, 2009. Please review this doc'wnent thoroughly.

Please notc that the mailing address, use location(s). maximum quantities ofradioactive materials. and the radiation safety officer are specific conditions ofyour liccWic. Ifyou have questions about making changes to your licensed activities, please contact the Radiation Management Unit to discuss the requirements for an amendment ofyour license.

Ifyou have any questions rewardina this letter or your license please contact Chas Etherton at 303-6923382 or [email protected]. Additional questions or comments can be directed to me at 303w

692~3423 or [email protected]. .

~7.Op:-t-Steve Tarlton, Unit Leader + Radiation Management Unit Hazardous Materials and Waste Management Division

Enclosure: Colo. 1053~O 1, Amendment No. 14

03W onN 300I~>lS l:>6L!9(;lBU Sl:01 60Bl/6l/al

STATE OF COLORADO RADIOACTIVE MATERIALS LICENSE

PurS\Wlt to the Colorado Radiation Control Act. Title 25. Article 11. Colorado Revised Statutes, and the State of Colorado Rules and Regulations Pertaining to Radiation Control (the Regulations). and in relilUlce on statements and representations heretofore made by tbe licensee designated below; a license is hereby issued authorizing such licensee to transfer, receive. possess and use the radioactive material(s) designated below; and to use such radioactive material(s) for the purpose(s) and at the place(s) designated below. This license is subject to all applicable rulcs, rcauJ.ations, and orders now or hctoafter in effect ofthe Colorado Department of Public Health and Environment and to any conditions specified below.

I. Licensee: Sky Ridge Medical Center

2. Mailing Address: 10101 RidgeGate Parkway, Lone Tree. Colorado 80124

3. License Nwnber: Colo. 1053-01, Amendment Number 14

4. Expiration date: July 31. 2013

r"", S. Authorized StoragclU$e Location: 10101 Rid.geGate Parkway, Lone Tree, Colorado 80124

6. The Designated R.i.diation Safety Officer is: Daniel W. Marvel, M.S.; The Designated Alternate Radiation Safety Officers are: Andrew Fisher, M.D.; Gregory L. Gibbs. M.S.; Bruce I. Goshorn, M.S.;-Richard McKeown. M.S.; Jennifer Stickel, Ph.D.; and Gerald A. White) M.S.

7. Radiation Safety Officer Contact Number: (303) 506·2461

8. Fee Category: 7.C

9. Reference Nwnber:

CONDITIONS

10. AuthoriRd Radioadive Materi.l ••d Use.;

A. The licensee is authorized to possess and use any Wlsealed radioactive material tor uptake, dilution, or excretion studies which has been prepared for medical use in accordance with the requirements of Section 7.30 of the Regulations. The licensee shall not possess more than 370 OBq (10 Ci) ofthese materials at anyone time.

T.e Revision 4 Licenac: N\). Colo. HlSHI, AmmdmlltlrNo, 14 '.lot7

03W ::>nN 300I~>tS


...-.... 11. Autborized Uecn:

A. Radioactive material authorized in Item 10 shaD be used by or under the supervision of the following 8uthori%ed users as specified:

.'.-'.,

....-.... ..

Name of Authorized User DelcripboQ of Materials authoriud Simeon Abramson, M.D. IO.A, 10.B. 10.0 Scott Robert Andersen. M.D. lO.A.IO.B Kim Baker. M.D. IO.A. lO.B. lO.n Lora D. Barke. M.D. 10.A. 10.B. 10.n Richard J. Bellon, M.D. lO.A. 1O.B. IO.n Ellen R. Blatt. M.D. IO.A. IO.B. 10.0 Janice Brennema.n.. M.D. IO.A. 10.B. IO.C.iL 10.C.iii. 10.0 OleJl Burmeister, M.D. 10.A, 1O.B. lO.C.ii, lO.e.iii. 10.n Dennis carter, M.D. IO.E. IO.F, 10.0 Vernon M. Chapman. M.D. 10.A. Ia.B. 10.0 Keith Dang]eis, M.D. IO.A, 10.8. 10.Coi. 10.0 Mark Dennis, M.D. IO.A 10B,10.0 Malcolm Dobrow. M.D. IO.A, IO.B. IO.C.ii. IO.C.iii, lO.n James Dreisbacb. M.D. 10.A 1O.B. IO.D William Dunfee. M.D. IO.A. 1a.B. 10.0 David Dw-uzan. M.D. '. 10.A. IO.B, 10.0 Andrew Fisher. M.D. IO.A. IO.B. lO.e.ii. IO.e.iii, IO.D Matthew Fleishman, M.D. IO.A. 10.B, 10.C.i, 10.D Kristin Freestone. M.D. IO.A. 10.B. 10.D Donald Frei, M.D. IO.A. 10.B, 10.0 Jeffrey Friedland. M.D. lOA. 10.B, 10.0 Laurence Oamor. M.D. IO.A. 10.B. 10.D JessAllcn . M.D. IO.A. 10.B. 10.C.ii, lO.C.iii Dennis Gri~ M.D. IO.A, 10.B, 10.0 Pbillip Gunther. M.D. lO.A 10;B Steven Heiss. M.D. lO.A, 10.B, 10.D David Hollander, M.D. IO.A. 1O.B. 10.0 Kent Hootman, M.D. 10.A.lO.B Odin Woodie HODoet. M.D. to.A, IO.B. 10.C.i. 10.D Paul Hsieh, M.D. IO.A, lO.B, IO.n Daniel Huddle, D.O. 10.A. 10.B, lO.D Kevin Johnson. M.D. IO.A,10.B.I0.D Bobby Konwoo Kan2. M.D. 10.A. lO.B. IO.C.i Jason Kelly, M.D. Kevin Lampert, M.D.

lO.A, 10.B. 1O.C.ii 10.C.iii IO.A. 10.8, IO.n

7,C Revisioa 4 Li\.'CIliiC ND, CDlo, IOS3..()1, Amcnclttwnt N\). 14

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F. The foUowing individuals are designated as authorized medical physicists for: A) manual Brachytherapy (90y Microspheres only); Timothy Johnson~ Ph.D.

12. General Requf:rementa:

A. The licensee shall comply with the all applicable provisions of the Regulations including: Part I, "General Provisions"; Parr 3, "Licensing ofRadioactive Material"; Part 4, "Standards for Protection Against Radiation"; Part 7, "Use ofRadionuclides in the Healing Arts"; Part 10, "Notices, Instructions and Reports to Workers; Inspections"; and Part 17, "Transportation ofRadioactive Material".

B. The Radiation Safety Officer shall maintain documentation of the training and experience for each person who uses radioactive materials under the supervision ofan authorized user.

C. Each person who uses radioactive material under the supervision of an authorized user shall be supervised and ~ceive instruction in accordance with the requirements of Section 7.10 and Section 10.3 ofthe ResuIations.

D. The licensee shall not transfer possession and/or control ofradioactive materials or items contaminated with radioactive material except: by transfer ofwaste to an authorized recipient; by transfer to a. specifically licensed recipient; or~ as provided otherwise by specific condition oftms license pursuant to the requirements ofPart 3. Section 3.22 ofthe Regulations.

E. Radioactive material authorized by Item 10 ofthis license shall be stored and used in a manner that will preclude possession or use by unauthorized personnel.

F. The licensee shall ensure that infonnation listed in this license is correct and accurate. The licCDSCe shall notify the Department in writina within ten (10) days whenever the information contained in Item. 1 tbrouab 7above is no longer current or determined to be inCOlTect.

G. The licensee may transport radioactive material or deliver mdioactivc material to a carrier for transport in accordance with the provisions ofPart 17 of the Regulations and the requirements of U.S. Department ofTransportation (49 CFR).

H. 'the licensee shall not make any false statement, representation, o.r certification in any application. :record, report. plan. or other docwnent regarding radiation levels. tests performed or radiation safety conditions or practices.

LicellK No. Colo. 1053-0 I, Amlllldllll'lnt No. 14 Pu&e S017

j;16Lt5(;Z;~(;L

STATE OF COLORADO RADIOACTIVE MATERlALS LICENSE

14. LiceDsee Commitments and Reference DocumeDts:

The State of Colorado Rules and Regulations Pertaining to Radiation Control shall aovem unless the licensee's statements. representations. and procedures contained in the application and conespondence are more restrictive than the Reaulations. Except as specifically provided otherwise by this license. the licensee shall possess and use radioactive material described in Item 10 ofthis license in accordance with the statements. representations, and procedw-es contained in:

A. the application and attachments dated June 24. 2008; and

B. the license correspondence and attachments dated OCtober 24. 2008; January 30,2009; March 1. 2009~ and AU¥USL 10,2009.

FOR 1HE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

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LicclI$1! No. Colo. IOSJ-<lI, ~nd_nl No. 14 Page 7of7

S0 39\;fd a3W OnN 38aI~~S v6l!!illBlL Sl:B! 600l/6l/B!

STATE OF COLORADO RADIOACTIVE MATERlALS LICENSE

B. The licensee is authorized. to possess and use any unsealed radioactive material for imaging Imd Jocali2.lltion studies which has been prepared for medical use in accordance with the requirements of Section 7.32 of the Regulations. The licensee shall not possess more than 370 OBq (10 Ci) ofthese materials at anyone time.

i. This authorization includes radioactive aerosols and gases in accordance with Section 7.34 of the: Regulations.

C. The licensee is authorized 10 possess and Uie any unsealed radioactive material fbi' which a written directive is required which has been prepared for medical use in accordance with the requirements of Section 1.36 of the Regulations. The licensee shall not possess more than 370 OBq (lOCi) of these materials at anyone time.

i. Use ofany unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required in accordance with Section 7.36.2 ofthe Regulations

iL Use limited to ora! administration of~ 1.22 G8q (33 mei) ofI·131 Sodium Iodide in accordance with Section 7.36.3 of the Regulations

iii. Use limited to oral administration of > 1.22 GBq (33 mei) of1-131 Sodium I04ide in accordance with Section 7.36.4 of the Reau]ations

D. The licensee is authorized 10 possess and use sealed sources in accordance with Section 7.40 of the Regulations for diagnosis. The licensee shall not possess more than 370 OBq (10 Ci) ofthese materials at anyone time.

~. -.

E. The licensee is authorized·to possess and use sealed sources in accordance with Section 7.42 ofthe Regulations for manual brachytherapy. The licensee shall not possess more than 370 Gaq (10 Ci) of these material" at anyone time.

F. The licensee is authorized to possess and use no more than 370 GBq (10 Ci) of Yttrium-90 microspheres for use in a Sirtex SIR-Spheres brachytherapy afterloader system in accordance with Section 7.62 ofthe Regulations. The total activity of Yttriwn-90 contained in each vial shall not exceed 4.0 GBq (108 mCi).

G. The licensee is authorized to possess and use no more than 80 OBq (2.16 Ci) of Yttriwn-90 microspheres for usc in aMOS Nordion TheraSphere therapy device in accordance with Section 1.62 of the Regulations. The total actiVity ofYttrium-90 contained in each vial shall not exceed 20 GBq (540 mel).

H. The licensee is authorized to possess and use any radioactive materials specified in Section 7.19 of the Re¥U1ations for check, calibration. and reference use.

1.C f<evl~ion 4 Lilll:ll~ No. Colo. 1053-111. Atnlltldmenl No. 14 I"qoZot"7

to6Lt9~Z;0z;LG3W anN 39aI~~S


Name of Authorized User Description of Materials autborJ2:ed Shannila Lingam-Nattamai. M.D. lO.A. 10.1:3, 10.0 Kay Lozano. M.D. 10.A. IO.B, 10.D James Luethke, M.D. 1a.A, 10.B. IO.D Eric Malden, M.D. 10.A. IO.B. 1O.n Charles. Mateskon, M.D. IO.F Christopher McLauf!hlin, M.D. IO.A. 10.B. 10.D Charles Nutting, D.O. IO.A. IO.B. lO.D, 10.F, 10.0 Richard Obrceon., M.D. IO.A. 10.B, 10.0 Michael one, M.D. IO.A. 10.B, ]0.0 Mccra Patel. M.D. IO.F Michael Payne, M.D. to.A, lO.B. IO.n David Porter, M.D. IO.A IO.B. 10.0 Peter Ricci. M.D. IO.A, IO.B, 10.0 John Roberts, M.D. IO.A. 10.B, 10.C.i. 10.0 Allison Sandberg, M.D. IO.A,10.8 Donald Schomer. M.D. 10.A, 10.B, 10.0 Stanley Smazal. M.D. 'IO.A. 10.B, 10.D Andrew Sonin,. M.D. 1O.A, 10.B, 10.0 William Steines. M.D. Ia.A. 10.B, 1a.C.H. 1O.C.iii~ 10.0 Jerome Sutherland. M.D. 1O.A, 10.B. 1O.C.ii. IO.e.iii. 10.n Samuel Wang, M.D: IO.A. 10.B, IO.C.i. 1O.D Shane Wheeler, M.D. 10.A.I0.B Donald Yee. M.D. IO.A. IO.B, 10.0

,~.

B. Radioactive material authorized in Item IO.H may be used by or under the supervision ofany ofthe authorized ~~ listed above and by the designated Radiation Safety Officer, zUten1atC RSOs and authomed medical physicists listed on this license.

C. The Radiation Safety Officer shall maintain documentation of the training and experience for each authorized user of radioactive materials. Ibis documentation shall include for each user: a copy of the applicable board certi:tlcatioDS. preceptor

. statements. and any other relevant traininj documents.

D. The following individuals are designated as authorized medical physicists for: A) therapeutic use of unsealed radioactive materials; and B) manual Brachytherapy: Stephen R. Armour, M.S.~ Bruce I. Goshorn, M.S.; and Shawn Meyer, M.S.

E. The following individuals are designated as authorized medical physicists for: A) therapeutic use of unsealed raWoactive materials; and B) manual Brachytherapy (:9Ov Microspheres only): Daniel W. Marvel, M.S.

,'-'.

7.C R$vision 4 LiUl\4$ NIl, Colo, 1053·0I, Amendment Nl>. 14 '.40£1

8Z:~t 6BBZ/6Z/01L9 39'>1d 03W onN 39CI~~S


13. Speejft~ RadiatiOD Safety Requirements:

A. The licensee shall acquire and maintain a current copy ofthe appJicable Sealed Source and Device Registry Evaluation for eacb brachytherapy device/source in use by the licensee. Unless alternative operating procedures are specificaJJy authorized by this license, the lic,;ensee shall comply with the safety precautions and limitations established in the applicable device registry eValuation.

B. Authorized users ofradioaetive materials in item IO.F, authorized users sUbsequently approved for use, and any designated authorized medical physicists. shall complete the Sirtex SIR-Spheres training prior to initial use.

C. The Sirtex SIR-Spheres therapy device shall be used with the Delivery Set and Delivery Box in accordance with the manufacturer'li instructions.

D. Authorized users ofradioaotive materials in Item 10.0, authorized users subsequently approved for use, and any designated authorized medical physicists. shall complete the MDS Nordion Tbera.Spherc Radiotherapy System training program prior to initial usc.

E. The MDS Nordion TberaSphere system shall be used with the Administr41tion Set and Accessory Kit in accordance with the manufacturer's instructions. Only the MONARCH 2S syringe Should be used with the Administration Set in accordance with r- .

the manufacturer's instructions.

F. The MDS Nordion ThClfaSphcre Radiotherapy System is approved by the U.S. Food and Drug Administration under the provisions ofa Humanitarian Device Exemption (HDE No. H9800006). Therefore. an Institutional Review Board is required to approve and monitor the use of the TheraSphere device.

G. Each scaled source authori~d in Item 10 of this license or in Section 7.19 ofthe Regulations shall be tested for leakage and/or contamination in accordance with the requirements of Section 1.20.2 of the Reaulations. and Part 4, Section 4.16 of the Regulations. at intervals not to exceed six (6) months.

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7.C Revlsioll 4 I..IQWC Nil. Colo. 1053-01. Amcncln'llllltNu. 14 pu".e6on

80 3E)'l;fd 03W OnN 390I~~S

STATE OF COLOMOO Bill Rilter, Jr., Governor Martha E. Rudolph. Executive Director

Dedicated to protecting and improving the health and environment of the people of Colorado

4300 Cherry Creek Dr. S. Laboratory Services Division Denver, Colorado 80246-1530 8100 Lowry Blvd. Phone (303) 692·2000 Denver, Colorado 80230-6928 TOO Line (303) 691-7700 (303) 692-3090 Colorado DepartmentLocated in Glendale, Colorado ofPublic Health htlp:llwww.cdphe.state.co.us and Environment

'JUL 132010

Centura Health - Littleton Adventist Hospital 7700 South Broadway Littleton, Colorado 80122

Attention: Daniel W. Marvel, M.S., Radiation Safety Officer

Re: License Amendment Colorado Radioactive Materials License Number Colo. 765-01

Enclosed is Radioactive Materials License Number Colo. 765-01, Amendment No. 19. The license has been amended as requested in a correspondence from Brian Lentz dated June 4,2010, with the exception discussed with Jennifer Stickel, Ph.D. in a phone conversation on July 7,2010. Please review this document thoroughly.

Please note that the mailing address, use location(s), maximum quantities of radioactive materials, and the radiation safety officer are specific conditions of your license. If you have questions about making changes to your licensed activities, please contact the Radiation Management Unit to discuss the requirements for an amendment of your license.

If you have any questions regarding this letter or your license please contact Chas Etherton at 303-6923382 or [email protected]. Additional questions or comments can be directed to me at 303692-3403 [email protected].

+~i~7{)~'~ Jennifer T. OpiJa, Unit Leader Radiation Management Unit Hazardous Materials and Waste Management Division

Enclosure: Colo. 765-01, Amendment No. 19

STATE OF COLOR!\DO RADIOACTIVE MATERIALS LICENSE Colorado Department

ofPuhlic Health and Environment

Pursuant to the Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes, and the State of Colorado Rules and Regulations Pertaining to Radiation Control (the Regulations), and in reliance on statements and representations heretofore made by the licensee designated below; a license is hereby issued authorizing such licensee to transfer, receive, possess and use the radioactive material(s) designated below; and to use such radioactive material(s) for the purpose(s) and at the place(s) designated below. This license is subject to all applicable rules, regulations, and orders now or hereafter in effect of the Colorado Department of Public Health and Environment and to any conditions specified below.

1. Licensee: Centura Health - Littleton Adventist Hospital

2. Mailing Address: 7700 South Broadway, Littleton, Colorado 80122

3. License Number: Colo. 765-01, Amendment Number 19

4. Expiration date: April 30, 2014

5. Authorized Storage/Use Location: 7700 South Broadway, Littleton, Colorado 80122

6. The Designated Radiation Safety Officer is: Daniel W. Marvel, M.S.; The Designated Alternate Radiation Safety Officers are: Stephanie Franz, M.S.; Jason Sellli, M.S.; and Jennifer Stickel, Ph.D.

7. Radiation Safety Officer Contact Number: (303) 506-2461

8. Fee Category: 7.e

9. Reference Number:

CONDITIONS

10. Authorized Radioactive Material and Uses:

A. The licensee is authorized to possess and use any unsealed radioactive material for uptake, dilution, or excretion studies which has been prepared for medical use in accordance with the requirements of Section 7.30 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

7.C Revision 5 Lkense No. Colo. 765·0 I, Amendment No. 19 Page 1 of6

57378 1


B. The licensee is authorized to possess and use any unsealed radioactive material for imaging and localization studies which has been prepared for medical use in accordance with the requirements of Section 7.32 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

1. This authorization includes radioactive aerosols and gases in accordance with Section 7.34 of the Regulations.

11. This authorization includes positron-emitting isotopes

C. The licensee is authorized to possess and use any unsealed radioactive material for which a written directive is required which has been prepared for medical use in accordance with the requirements of Section 7.3 6 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

1. Use of any unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required in accordance with Section 7.36.2 of the Regulations

11. Use limited to oral administration of$1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with S.ection 7..36.3 of the Regulations

iii. Use limited to oral administration of > 1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with Section 7.36.4 ofthe Regulations

D. The licensee is authorized to possess and use sealed sources in accordance with Section 7A2 of the Regulations for manual brachytherapy. The licensee shall not P9ssess more than 370 GBq (10 Ci) of these materials at anyone time.

E. The licensee is authorized to possess and use no more than 160 GBq (4.32 Ci) ofY-90 microspheres for use in a Sirtex SIR-Spheres brachytherapy afterloader system in accordance with Section 7.62 ofthe Regulations. The total activity ofY-90 contained in each vial shall not exceed 5.75 GBq (175 mCi).

F. The licensee is authorized to possess and use any radioactive materials specified in Section 7.19 of the Regulations for check, calibration, and reference use.

G. The licensee is authOlized to possess and use sealed sources containing not more than 11.1 GBq (300 mCi) each of Gadolinium 153 (153Gd) for attenuation correction purposes for computerized emission tomography images.

7.C Revision 5 License No. Colo. 765-01, Amendment No. 19 Page 2 ofG


Authorized Users:

A. Radioactive material authorized in Item 10 shall be used by or under the supervision of the following authorized users as specified:

Name of Authorized User Description of Materials Authorized Simeon D. Abramson, M.D. 10.A,10.B Scott Robelt Anderson, M.D. 1O.A,1O.B Kim B. Baker, M.D. 10.A,1O.B Lora Barke, D.O. 10.A,10.B Richard J. Bellon, M.D. 10.A,10.B Ellen R. Blatt, M.D. 10.A,10.B Janice K. Brenneman, M.D. 1O.A, 10.B, 10.C.ii, 10.C.iii Glen E. Burmeiester, M.D. 10.A, 10.B, 10.C.ii, 1O.C.iii Dennis Carter, M.D. 10.E Vernon M. Chapman, M.D. 10.A, 10.B Keith C. Dangleis, M.D. 1O.A , 10.B, 10.C.i Malcolm S. Dobrow, M.D. 10.A, 10.B, 10.C.ii, 10.Coiii James N. Dreisbach, M.D. 10.A,10.B "William R. Dunfee, M.D. 10.A,10.B David H. Dtmgan, M.D. 10.A, 10.B Andrew 1. Fisher, M.D. 10.A, 10.B, 10.C.ii, 10.C.iii Matthew J. Fleishman, M.D. 10.A, 10.B, 10.C.i Kristin A. Freestone, M.D. 10.A,10.B Donald F. Frei, M.D. 10.A,10.B Jeffrey A. Friedland, M.D. 10.A, 10.B Jess Allen Graham, M.D. 10.A, 10.B, 10.C,i Lawrence F. Gaynor, M.D. 10.A,10.B Dennis J. Griffin, M".D. 10.A,10.B Phillip Gunther, M.D. 10.A,1O.B Steven G. Heiss, M.D. 10.A, 10.B David S. Hollander, M.D. 10.A,10.B Kent Hootman, M.D.

"----10.A, 10.B

OrlinW. Hopper II, M.D. 10.A, 10.B, 1O.C.i Paul Sek-Bin Hsieh, M.D. 10.A, 10.B Daniel C. Huddle, D.O. 10.A, 10.B Kevin K. Johnson, M.D. 10.A,10.B Bobby Konwoo Kang, M.D. 10.A, 10.B, ] O.C.i Jason L. Kelly, M.D. 1O.A, 1O.B, 1O.C.ii, 1O.C.iii Kevin 1. Lampert, MB, BCb 10.A,1O.B Sharmila C. Lingam-Nattamai, MB, BS 10.A,10.B Kay D. Lozano, M.D. 1O.A,1O.B

7.C Revision :) License No. Colo" 765-01, Amendment No. 19 Page 3 of6


Name of Authorized User Description of Materials Authorized James M. Luethke, M.D. IO.A, IO.B Erik S. Malden, M.D. IO.A, IO.B Christopher G. McLaughlin, M.D. IO.A, IO.B ChmlesNutting,D.O. IO.A, IO.B, IO.E Richard G. Obregon, M.D. 1O.A,1O.B Michael T. Otte, M.D. IO.A,lO.B Michael 1. Payne, M.D. IO.A, IO.B Meera Patel, M.D. IO.E David 1. Porter, M.D. IO.A, IO.B Peter E. Ricci," Jr., M.D. IO.A, IO.B John C. Riley, M.D. IO.A, IO.B, IO.C.li, IO.C.iii, 1O.D John F. Roberts, M.D. 1O.A, IO.B, IO.C.i, IO.D Allison Sandberg, M.D. IO.A, IO.B David F. Schomer, M.D. IO.A,lO.B Stanley F. Smazal, Jr., M.D. IO.A, lO.B Andrew H. Sonin, M.D. 1O.A, "I.O.B Brooke Spencer, M.D. lO.E William J. Steines, M.D. IO.A, lO.B, lO.C.ii, 1O.C.iii Jerome D. Sutherland, M.D. IO.A, IO.B, IO.C.ii, 1O.C.iii Samuel C. Wang, M.D. IO.A, IO.B, IO.C.i Shane Wheeler, M.D. IO.A,lO.B Dominic C. Yee, M.D. IO.A,lO.B

B. Radioactive material authorized in Item lO.F and IO.G may be used by or under the supervision of any of the authorized users listed above and by the designated Radiation Safety Officer, alternate RSOs, and authorized medical physicists listed on this license.

C. The Radiation Safety Officer shall maintain documentation of the training and experience for each authorized user of radioactive materials. This documentation shall include for each user: a copy of the applicable bomd certifications, preceptor statements, and any other relevant training documents.

D. The following individuals are designated as authorized medical physicists for: A) therapeutic use of unsealed radioactive materials and B) manual Brachytherapy: StephenR. Armour, M.S.; Bruce 1. Goshorn, M.S.; and Tim Johnson, M.S.

E. The following individuals are designated as authorized medical physicists for: A) therapeutic use of unsealed radioactive materials and B) Sirtex SIRNSpheres therapy: Daniel W. Marvel, M.S.; David Pascoe, M.S.; Jason Senn, M.S.; and Jennifer Stickel, Ph.D.

7.C Revision 5 License No. Colo. 765-01, AmendmentNo. 19 Page 4 ofG


2. General Requirements:

A. The licensee shall comply with the all applicable provisions of the Regulations including: Part 1, "General Provisions"; Part 3, "Licensing of Radioactive Material"; Part 4, "Standards for Protection Against Radiation"; Part 7, "Use of Radionuclides in the Healing Arts"; Part 10, "Notices, Instructions and Reports to Workers; Inspections"; and Part 17, "Transportation ofRadioactive Material".

B. The Radiation Safety Officer shall maintain documentation of the training and experience for each person who uses radioactive materials under the supervision of an authorized user.

C. Each person who uses radioactive material under the supervision of an authorized user shall be supervised and receive instruction in accordance with the requirements of Section 7.1 0 and Section 10.3 ofthe Regulations.

D. The licensee shall not transfer possession anci/or contTol of radioactive materials or items contaminated with radioactive material except: by transfer ofwaste to an authorized recipient; by transfer to a specifically licensed recipient; or, as provided otherwise by specific condition of this Jicense pursuant to the requirements of Part 3, Section 3.22 of the Regulations.

E. Radioactive material authorized by Item 10 of this license shall be stored and used in a manner that will preclude possession or use by unauthotizedpetsonnel.

F. The licensee shall ensure that information listed in this licen·se is con'ect and accurate. 'flle licensee shall notify the Department in writing within ten (l0) days whenever the information contained in Items 1 through 7 above is no longer current or determined to be incorrect.

G. The licensee may transp011 radio~ctive material or deliver radioactive material to a caITier for transport in accordance with the provisions' of Part 17 of the Regulations and the requirements of U.S. Department of Transportation (49 CFR).

H. The licensee shall not make any false statement, representation, or certification in any application, record, report, plan, or other document regarding radiation levels, tests performed or radiation safety conditions or practices.

Specif1c Radiation Safety Requirements:

A. Each sealed source authorized in Hem 10 of this license or in Section 7.19 ofthe Regulations shall be tested for leakage and/or contamination in accordance with the requirements of Section 7.20.2 of the Regulations, and Part 4, Section 4.16 of the Regulations, at intervals not to exceed six (6) months.

7.C Revision 5 License No. Colo. 765-01, Al1Icl\dl1lcnlNo. J9 Page 5 of6


B. The licensee shall acquire and maintain a current copy of the applicable Sealed Source and Device Registry Evaluation for each brachytherapy device/source in use by the licensee. Unless alternative operating procedures are specifically authorized by this license, the licensee shall comply with the safety precautions and limitations established in the applicable device registry evaluation.

C. Authorized users ofradioacti've material's in Item 10.E and any authorized users subsequently approved for use, shalt" complete the Sirtex SIR-Spheres training prior to initial use. '. ,

D. The Sirtex SIR..Spheres therapy device shall be used with the Delivery Set and Delivery Boxin accordance with the manufacturers instructions.

2. Special License Requirements:

A. Installation, relocation; maintenance; repair, leak testing and initial.survey of devices that contain radioactive material and replacement, and disposal of sealed sources that contain radioactive· materialth:at is used in devices shall be performed only by the manufacturer, or by other persons who are specifically authorized by the U.S. Nuclear Regulatory Coinmissien ;or an:Agreement State having jurisdiction over the possession and use of accelerator pr,?duce~ radioactive material.

3. Licensee Commitments and Reference Documents: ;j"•• : .. ':. ". \.: ... : . , '

The State of Colorado Rules aiia Regtiiati01'is 'Pertaining to Radiation Control shall govern unless the licensee's statements; representations, and procedures contained in the application and correspondence are more restrictive than the Regulations. Except as specifically provided otherwise by this license, the licensee shall possess and use radioactive material described in Item 10 of this license in accordance with the statements, representations, and procedures contained in:

A. the application and attachments dated March 30,2009; and

B. the license correspondence and attachments dated March 10, 2009; August 10, 2009; November 30, 2010; March 25, 2010 (email); March 29,2010 (email); April 20, 2010 (email); and June 4, 2010.

FOR THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

,Date:M 13, 2010 ~7. 0;:J.a-By:

7.C Revision 5 License No, Colo. 765-01, Amendment No. 19 Page 6 of6

STATE OF COLORADO RADIOACTIVE MATERIALS LICENSE Colorado Department

ofPublic Health and Environment

Pursuant to the Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes, and the State of Colorado Rules and Regulations Pertaining to Radiation Control (the Regulations), and in reliance on statements and representations heretofore madeby the licensee designated below; a license is hereby issued authorizing such licensee to transfer, receive, possess and use the radioactive material(s) designated below; and to use such radioactive material(s) for the purpose(s) and at the place(s) designated below. This license is subject to all applicable rules, regulations, and orders now or hereafter in effect of the Colorado Department of Public Health and Environment and to any conditions specified below.

1. Licensee: Centura Health - Porter Adventist Hospital

2. Mailing Address: 2525 South Downing Street, Denver, Colorado 80210

3. License Number: Colo. 210-01, Amendment No: 101

4. Expiration date: September 30,2013

5. Authorized StoragelUse Location: 2525 South Downing Street, Denver, Colorado 80210

6. The Designated Radiation Safety Officer is: Daniel Marvel, M.S. The Designated Alternate Radiation Safety Officers are: Michael J. Bailey, M.S; Stephanie Franz, M.S.; Gregory Lee Gibbs, M.S.; Richard McKeown, M.S.; Shawn Meyer, M.S.; Jennifer Stickel, Ph.D.; and Gerald A. White, M.S.



9. Reference Number:

CONDITIONS


A. The licensee is authorized to possess and use any unsealed radioactive material for uptake; dilution, or excretion studies which has been prepared for medical use in accordance with the requirements of Section 7.30 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

7.C Revision 5 License No. Colo. 210-01 Amendment No. 101 Page 1 of?


B. The licensee is authorized to possess and use any unsealed radioactive material for imaging and localization studies which has been prepared for medical use in accordance with the requirements of Section 7.32 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

1. This authorization includes radioactive aerosols and gases in accordance with Section 7.34 of the Regulations.

11. This authorization includes positron-emitting isotopes

C. The licensee is authorized to possess and use any unsealed radioactive material for which a written directive is required which has been prepared for medical use in accordance with the requirements of Section 7.36 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

1. Use limited to oral administration of:::; 1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with Section 7.36.3 of the Regulations

11. Use limited to oral administration of > 1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with Section 7.36.4 of the Regulations.

D. The licensee is authorized to possess and use sealed sources in accordance with Section 7.40 of the Regulations for diagnosis. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

E. The licensee is authorized to possess and use sealed sources in accordance with Section 7.42 of the Regulations for manual brachytherapy. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

F. The licensee is authorized to possess and use no more than 30 GBq (810 mCi) ofY-90 microspheres for use in a Sirtex SIR-Spheres brachytherapy afterloader system in accordance with Section 7.62 of the Regulations. The total activity ofY-90 contained in each vial shall not exceed 4.89 GBq (132 mCi).

G. The licensee is authorized to possess and use no more than 60 GBq (1620 mCi) ofY90 microspheres for use in a MDS Nordion TheraSphere therapy device in accordance with Section 7.62 of the Regulations. The total activity ofY-90 contained in each vial shall not exceed 20 GBq (540 mCi).

H. The licensee is authorized to possess and use 2 sealed sources in accordance with Section 7.48 of the Regulations for use in a Varian Medical Systems transportable VariSource HDR Remote Afterloading Brachytherapy Unit. The total activity shall not exceed 777 GBq (21 Ci) of Ir-192. The source activity may not exceed 370 GBq (10 Ci) at the time of installation.

7.C Revision 5 License No. Colo. 210-0 I Amendment No. 101 Page 2 of7


I. The licensee is authorized to possess and use not more than 37 GBq (1 Ci) of Gadolinium 153 (153Gd) in North American Scientific model MED-360l and Isotope Products Laboratory model NES-8412 sealed sources, for use in an ADAC Vantage Non-uniform Attenuation Correction System for attenuation correction determinations.

J. The licensee is authorized to possess and use sealed sources containing not more than 2.4 GBq (65 mCi) of Germanium 68 (68Ge) in sealed sources (GE Part No. 46-31 1375GI) in a GE PET Advance Attenuation Correction System for attenuation correction determinations.

K. The licensee is authorized to possess and use any radioactive materials specified in Section 7.19 of the Regulations for check, calibration, and reference use.

11. Authorized Users:

A. Radioactive material authorized in Item IO shall be used by or under the supervision of the following authorized users as specified:

Name of Authorized User Description of Materials Authorized Simeon Abramson, M.D IO.A,IO.B and IO.D Scott R. Anderson, M.D IO.A,IO.B and IO.D Kim Baker, M.D. IO.A,IO.B and IO.D Richard J. Bellon, M.D. IO.A, IO.B and IO.D Ellen R. Blatt, M.D IO.A,IO.B and IO.D Janice Brenneman, M.D' IO.A, I O.B, IO.C.i, IO.C.ii and IO.D Lora Burke, D.O. IO.A, IO.B Glen Burmeister, M.D. IO.A,IO.B, IO.C.i, IO.C.ii and IO.D Vernon M. Chapman, M.D. IO.A,IO.B and IO.D Keith Dangleis, M.D. IO.A,IO.B, IO.C.i, IO.C.ii and IO.D Mark Dennis, M.D. IO.A,IO.B and IO.D Malcolm Dobrow, M.D. IO.A,IO.B, IO.C.i, IO.C.ii and IO.D James Dreisbach, M.D. IO.A,IO.B and IO.D William Dunfee, M.D. IO.A,IO.B and IO.D David Dungan, M.D. IO.A,IO.B and IO.D Andrew Fisher, M.D. IO.A,IO.B, IO.C.i, IO.C.ii and IO.D Matthew Fleishman, M.D. IO.A,IO.B, IO.C.i, IO.C.ii and IO.D Kristin Freestone, M.D. IO.A,IO.B and IO.D Donald Frei, M.D. IO.A,IO.B and IO.D Jeffrey Friedland, M.D. IO.A,IO.B and IO.D Laurence Gaynor, M.D. IO.A,IO.B and IO.D Jess Allen Graham, M.D. IO.A,IO.B and IO.C.i, IO.C.ii Dennis Griffin, M.D. IO.A,IO.B and IO.D



Name of Authorized User Description of Materials Authorized Phillip Gunther, M.D. 10.A,10.B and 10.D Steven Heiss, M.D. 10.A,10.B and 10.D David Hollander, M.D. 10.A,10.B and 10.D Kent Hootman, M.D. 10.A,10.B Orlin Woodie Hopper, M.D. 10.A,10.B, C i, ii and 10.D Paul Hsieh, M.D. 10.A,10.B and 10.D Daniel Huddle, D.O. 10.A,10.B and 10.D Kevin Johnson, M.D. 10.A,10.B and 10.D Bobby Konwoo Kang, M.D. 1O.A, 10.B, 10.C.i, 10.C.ii and 10.D Jason Kelly, M.D. 10.A,10.B, 10.C.i, 10.C.ii and 10.D Kevin Lampert, M.D. 1O.A, 10.B and 10.D Sharmila Lingam-Nattamai, M.D. 10.A,10.B and 10.D Kay Lozano, M.D. 1O.A, 1O.B and 10.D James Luethke, M.D. 10.A,10.B and 10.D Eric Malden, M.D. 1O.A, 10.B and 10.D Christopher McLaughlin, M.D. 10.A,10.B and 10.D Charles Nutting, D.D.------- 10.A,1O.B and 10.D Richard Obregon, M.D. 1O.A, 10.B and 10.D Michael Otte, M.D. 1O.A, 10.B and 10.D Michael Payne, M.D. 10.A,10.B and 10.D David Porter, M.D. 1O.A, 1O.B and 10.D Seth D. Reiner, M.D. 10.E, 10.F, 10.G and 10.H Peter Ricci, M.D. 1O.A, 10.B and 10.D John Roberts, M.D. 10.A,10.B, 10.C.i, 10.C.ii and 10.D Allison Sandberg, M.D. 10.A,10.B Donald Schomer, M.D. 10.A,10.B and 10.D Stanley Smazal, M.D. 1O.A, 10.B and 10.D Andrew Sonin, M.D. 10.A,10.B and 10.D William Steines, M.D. 10.A,10.B, 10.C.i, 10.C.ii and 10.D Jerome Sutherland, M.D. 10.A,10.B, 10.C.i, 10.C.ii and 10.D Samuel Wang, M.D. 10.A,10.B, 10.C.i, 10.C.ii and 10.D Shane Wheeler, M.D. 10.A, 10.B Donald Yee, M.D. 10.A,10.B and 10.D

B. Radioactive material authorized in Item 10.I, 10.J, and 10.K may be used by or under the supervision of any of the authorized users listed above and by the designated Radiation Safety Officer, alternate RSOs, and authorized medical physicists listed on this license.

7.C Revision 5 License No. Colo. 210-01 Amendment No. 101 Page 4 of7


C. The following individual is designated as authorized medical physicist for: A) therapeutic use of unsealed radioactive materials; B) manual Brachytherapy; C) Low Dose Rate (LDR) Brachytherapy; D) Medium Dose Rate (MDR) Brachytherapy; E) High Dose Rate (HDR) Brachytherapy: Greg Chaney, M.S.

D. The following individual is designated as authorized medical physicist for: A) High Dose Rate (HDR) Brachytherapy: Arnold Z. Cohen, M.S.

E. The following individuals are designated as authorized medical physicists for: A) SIRTEX SIRSPHERES; and B) MDS NORDION THERASPHERES: Daniel Marvel, M.S., Shawn Meyer, M.S., Gayle Harnish, M.S.

F. The Radiation Safety Officer shall maintain documentation of the training and experience for each authorized user of radioactive materials. This documentation shall include for each user: a copy of the applicable board certifications, preceptor statements, and any other relevant training documents.


A. The licensee shall comply with the all applicable provisions of the Regulations including: Part 1, "General Provisions"; Part 3, "Licensing of Radioactive Material"; Part 4, "Standards for Protection Against Radiation"; Part 7, "Use of Radionuclides in the Healing Arts"; Part 10, "Notices, Instructions and Reports to Workers; Inspections"; and Part 17, "Transportation of Radioactive Material".

B. The Radiation Safety Officer shall maintain documentation of the training and experience for each person who uses radioactive materials under the supervision of an authorized user.

C. Each person who uses radioactive material under the supervision of an authorized user shall be supervised and receive instruction in accordance with the requirements of Section 7.10 and Section 10.3 of the Regulations.

D. The licensee shall not transfer possession and/or control of radioactive materials or items contaminated with radioactive material except: by transfer of waste to an authorized recipient; by transfer to a specifically licensed recipient; or, as provided otherwise by specific condition of this license pursuant to the requirements of Part 3, Section 3.22 of the Regulations.

E. Radioactive material authorized by Item 10 of this license shall be stored and used in a manner that will preclude possession or use by unauthorized personnel.



F. The licensee shall ensure that information listed in this license is correct and accurate. The licensee shall notify the Department in writing within ten (10) days whenever the information contained in Items 1 through 7 above is no longer current or determined to be incorrect.

G. The licensee may transport radioactive material or deliver radioactive material to a carrier for transport in accordance with the provisions of Part 17 of the Regulations and the requirements of U.S. Department of Transportation (49 CFR).


13. Specific Radiation Safety Requirements:

A. Each sealed source authorized in Item 10 of this license or in Section 7.19 ofthe Regulations shall be tested for leakage and/or contamination in accordance with the requirements of Section 7.20.2 of the Regulations, and Part 4, Section 4.16 of the Regulations, at intervals not to exceed six (6) months.

. B. Source installation and maintenance of the HDR device authorized in Item 10.H shall be performed in accordance with Section 7.49 of the Regulations.

C. Authorized users of radioactive materials in Item 10.F, authorized users subsequently approved for use, and any designated authorized medical physicists, shall complete the Sirtex SIR-Spheres training prior to initial use.

D. The Sirtex SIR-Spheres therapy device shall be used with the Delivery Set and Delivery Box in accordance with the manufacturer's instructions.

E. Authorized users of radioactive materials in Item 10.G, authorized users subsequently approved for use, and any designated authorized medical physicists, shall complete the MDS Nordion TheraSphere Radiotherapy System training program prior to initial use.

F. The MDS Nordion TheraSphere system shall be used with the Administration Set and Accessory Kit in accordance with the manufacturer's instructions. Only the MONARCH 25 syringe should be used with the Administration Set in accordance with the manufacturer's instructions.

G. The MDS Nordion TheraSphere Radiotherapy System is approved by the U.S. Food and Drug Administration under the provisions of a Humanitarian Device Exemption (HDE No. H9800006). Therefore, an Institutional Review Board is required to approve and monitor the use of the TheraSphere device.



H. The licensee is authorized to transport radioactive material that is authorized in Item 10.H to and from other licensed facilities in Colorado that are authorized for use of this material in the VariSource HDR Remote Afterloading Brachytherapy Unit. The licensee shall maintain records appropriate for the transfer of radioactive material between licensees and shall provide a transfer schedule to this Department upon request.

1. Leak tests of the sealed sources in the VariSource HDR remote afterloading brachytherapy device are not required prior to transfer between hospitals, provided that: transfer is made in anticipation of, or after a scheduled use for therapy; all leak tests that are otherwise required have been performed on schedule and the results are satisfactory; and, sealed sources have not been removed from the device since their most recent leak test.

1. The licensee is authorized to use radioactive material in Items 10.A, lOB and 10.H in research protocols as described in the licensee's correspondence to the Department dated April 2, 2007.

K. The licensee shall acquire and maintain a current copy of the applicable Sealed Source and Device Registry Evaluation for each brachytherapy device/source in use by the licensee. Unless alternative operating procedures are specifically authorized by this license, the licensee shall comply with the safety precautions and limitations established in the applicable device registry evaluation.

14. Licensee Commitments and Reference Documents:

The State ofColorado Rules and Regulations Pertaining to Radiation Control shall govern unless the licensee's statements, representations, and procedures contained in the application and correspondence are more restrictive than the Regulations. Except as specifically provided otherwise by this license, the licensee shall possess and use radioactive material described in Item 10 of this license in accordance with the statements, representations, and procedures contained in:

A. the application and attachments dated August 28,2008; and

B. the license correspondence and attachments dated August 29,2008; November 17, 2008 (email); November 18, 2008 (email); December 3, 2008 (email); December 12, 2008 (email); March 10,2009; August 10,2009 (two documents received August 25, 2009 and September 10, 2009); and April 26, 2010.

FOR THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Date: By: _


STATE OF COLORADO Bill Riller, Jr., Governor Martha E. RUdolph, Executive Director

Dedicated to protecting and improving the health and environment of the people of Colorado

4300 Cherry Creek Dr. S. Laboratory Services Division Denver, Colorado 80246-1530 8100 Lowry Blvd. Phone (303) 692·2000 Denver, Colorado 80230·6928 TOO Line (303) 691·7700 Located in Glendale, Colorado

(303) 692·3090 Colorado Department ofPublic Health

http://www.cdphe.state.co.us and Environment

'JUL 13Z010

Rocky Mountain Cancer Centers of Colorado 7951 East Maplewood Avenue, Suite 300 Greenwood Village, Colorado 80111

Attention: Bruce 1. Goshorn, M.S., Radiation Safety Officer

Re: License Amendment Colorado Radioactive Materials License Number Colo. 1012-01

Enclosed is Radioactive Materials License Number Colo. 1012-01, Amendment No. 23. The license has been amended as requested in correspondence from Bruce 1. Goshorn, M.S. and Elaine McDonald dated June 23, 2010. Please review this document thoroughly.

Additionally, your license has been amended based on Departmental changes to the appearance and content of licenses. While most changes are of a fonnatting nature, there are also requirements that have been added, strengthened, or clarified in the license. Also, in some instances, license conditions may have been removed from the license where equivalent requirements have been incorporated into the Regulations. Again, we encourage you to review the license thoroughly and contact us should you have' questions.

Please note that the mailing address, use location(s), maximum quantities of radioactive materials, and the radiation safety officer are specific conditions of your license. If you have questions about making changes to your licensed activities, please contact the Radiation Management Unit to discuss the requirements for an amendment of your license.

If you have any questions regarding this letter or your license please contact James DeWolfe at 303-6923444 or [email protected]. Additional questions or comments can be directed to me at 303692-3403 or [email protected].

i:.~u~~ Radiation Management Unit Hazardous Materials and Waste Management Division

Enclosure: Colo. 1012-01, Amendment No. 23

STATE OF COLOMOO RADIOACTIVE MATERIALS LICENSE ColoraOO Department

ofPublic Health and Environment

Pursuant to the Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes, and the State of Colorado Rules and Regulations Pertaining to Radiation Control (the Regulations), and in reliance on statements and representations heretofore made by the licensee designated below; a license is hereby. issued authorizing such licensee to transfer, receive, possess and use the radioactive material(s) designated below; and to use such radioactive materia1(s) for the purpose(s) and at the place(s) designated below. This license is subject to all applicable rules, regulations, and orders now or hereafter in effect of the Colorado Department of Public Health and Environment and to any conditions specified below.

1. Licensee: Rocky Mountain Cancer Centers of Colorado

2. Mailing Address: 7951 East Maplewood Avenue, Suite 300 Greenwood Village, Colorado 80111

3. License Number: Colo. 1012-01, Amendment Number 23

4. Expiration date: May 31, 2011

5. Authorized Storage/Use Location(s): See Condition 14

6. The Designated Radiation Safety Officer is: Bruce I. Goshorn, M.S. The Designated Alternate Radiation Safety Officer(s) are: Stephen R. Annour, M.S.; Timothy Johnson, Ph.D. and Michael Tallhamer, M.S.



9. Reference Number: PET

CONDITIONS


A. The licensee is authorized to possess and use any unsealed Positron Emitting radioactive material for uptake, dilution, or excretion studies which has been prepared for medical use in accordance with the requirements of Section 7.30 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

7.C Revision 5 License No. Colo. 1012-01, Amendment No. 23 Page 1 of7


B. The licensee is authorized to possess and use any unsealed Positron Emitting radioactive material for imaging and localization studies which has been prepared for medical use in accordance with the requirements of Section 7.32 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) of these materials at anyone time.

C. The licensee is authorized to possess and use any unsealed radioactive material for which a written directive is required which has been prepared for medical use in accordance with the requirements of Section 7.36 of the Regulations. The licensee shall not possess more than 370 GBq (10 Ci) ofthese materials at anyone time.

1. Use limited to oral administration of ~ 1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with Section 7.36.3 of the Regulations

ii. Use limited to oral administration of > 1.22 GBq (33 mCi) ofI-131 Sodium Iodide in accordance with Section 7.36.4 of the Regulations

iii. Use limiteq to parenteral administration in accordance with Section 7.36.5 of the Regulations.

D. The licensee is authorized to possess and use not more than 4 sealed source(s) for patient attenuation corrections and for Positron Emission Tomography (PET) camera quality control as part of the GE Discovery ST PET scanner. Each sealed source contains not more than 55.5 MBq (1.5 mCi) of Germanium-68 (68Ge).

E. The licensee is authorized to possess and use any radioactive materials specified in Section 7.19 of the Regulations for check, calibration, and reference use.

11. Authorized Users:

A. Radioactive material authorized in Item 10 shall be used by or under the supervision of the following authorized users as specified:

Name of Authorized User Description of Materials authorized Norman O. Aarestad, M.D. 1O.A, 10.B, 1O.C.i, 1O.C.ii Andrew G. Antell, M.D. 10.C.i, 10.C.ii, 10.C.iii Christopher R. Bartlett, M.D. 10.A, 10.B Matthew H. Blomquist, M.D. 1O.A,10.B Eric Bode, M.D. 1O.A,10.B Charles R. Bowles, M.D 10.A, 10.B Carlos A. Cardenas, M.D. 10.A,10.B Bert R. Carrollo, M.D. IO.A,10.B Dennis L. Carter, M.D. IO.C.i, IO.C.ii Daniel T. Chin, M.D. IO.C.iii Paul V. Connaughton, M.D. IO.A,10.B

7.C Revision 5 License No. Colo. 1012·0I, Amendment No. 23 Page 2 of7


Name of Authorized User Description of Materials authorized Keith C. Dangleis, M.D. IO.A, IO.B, IO.C.i, IO.C.ii William E. Daniel, M.D. IO.C.i, IO.C.ii Lawrence L. Emmons, M.D. IO.A, IO.B, IO.C.i, IO.C.ii Richard M. Finer, M.D. IO.A,IO.B Matthew J. Fleishman, M.D. IO.A, IO.B and IO.C.i, IO.C.ii Alexandra A. Fortner, M.D. IO.A, IO.B, IO.C.i, IO.C.ii Garret M. Gannuch, M.D. IO.A,IO.B John P. Gerhold, M.D. IO.A, IO.B, IO.C.i, IO.C.ii Monte E. Golditch, M.D. IO.A,IO.B Warren D. Goldstein, M.D. IO.A,IO.B David Gordon Goodbee, M.D. IO.A,IO.B Brenda C. Grabb, M.D. IO.A,IO.B Jess Allen Graham, M.D. IO.A,IO.B Stacy L. Greenspan, D.O. IO.A,IO.B Philip B. Gunther, M.D. IO.A, IO.B Hilarie Joyce Gutierrez, M.D. IO.A, IO.B Horacio Gutierrez, M.D. IO.A,IO.B Robert E. Helgans, M.D. IO.A, IO.B Orlin W. Hopper II, M.D. IO.A, IO.B, IO.C.i, IO.C.ii Kathryn T. Howell, M.D. IO.C.iii Steven R. Hughes, M.D. IO.A, IO.B Gustavo L. Isuani, M.D. IO.A,IO.B Robert J. Johnston, M.D. IO.A, IO.B Jennifer L. Kemp, M.D. IO.A,IO.B Paul D. King, M.D. IO.A,IO.B William C. Klingensmith III, M.D. IO.A, 10.B, 10.C.i, IO.C.ii Craig M. Kornbluth, M.D. 10.A, 10.B Christine Anne Lamoureux, M.D. IO.A, IO.B Robert M. LaPorte, M.D. 10.C.i, IO.C.ii Charles E. Leonard, II, M.D. 10.C.i, IO.C.ii Matthew A. Lowery, M.D. 1O.A,10.B Karl E. Magsamen, M.D. IO.A,10.B Jie Mao, M.D. IO.A, IO.B Lee K. McNeely, M.D. IO.C.i, 10.C.ii Brian K. Metz, M.D. 10.A,10.B Stephen M. Miller, M.D 10.A, 10.B Roger D. Nichols, M.D. 10.A,10.B Christopher A. Nusser, M.D. 1O.A,10.B David A. Oppenheimer, M.D. IO.A,10.B Meera Patel, M.D. 10.C.iii



Name of Authorized User Description of Materials authorized Nicole 1. Restauri, M.D. 1O.A,10.B Bradford 1. Robinson, M.D. 1O.A,10.B Barry A. Schoelch, D.O. 10.A,10.B Chad C. Schooley, M.D. 10.A,10.B Robert H. Sherrier, M.D. 10.A,10.B Scott Smith, M.D. 1O.A,10.B Thomas D. Suby-Long, M.D. 10.A,10.B Jerome D. Sutherland, M.D. 10.A, 10.B, 10.C.i, 1O.C.ii Sachin Kumar Talusani, M.D. 1O.A,10.B Andrew S. Tanner, M.D. 10.C.iii William Brent Wahl, M.D. 1O.A,10.B Samuel C. Wang, M.D. 1O.A, 10.B, 1O.C.i, 1O.C.ii Wayne W. Wenzel, M.D. 10.A, 10.B, 10.C.i, 1O.C.ii Nicholas Wickersham, M.D. 1O.A,10.B James P. Wilson, M.D. 10.A, 10.B, 10.C.i, 10.C.ii Karl A. Wolff, M.D. 10.A,10.B 1. Werner Ziegler, M.D. 10.A,10.B

B. Radioactive material authorized in Items 1O.D and 1O.E may be used by or under the supervision of any of the authorized users listed above and by the designated Radiation Safety Officer and alternate RSOs listed on this license.

C. The following individuals are designated as authorized medical physicists for: A) therapeutic use ofunsealed radioactive materials: Stephen R. Armour, M.S.; Bruce I. Goshorn, M.S; Timothy Johnson Ph.D; Michael Ta1lhamer, M.S.

D. The Radiation Safety Officer shall maintain documentation of the training and experience for each authorized user of radioactive materials. This documentation shall include for each user: a copy of the applicable board certifications, preceptor statements, and any other relevant training documents.


A. The licensee shall comply with the all applicable provisions of the Regulations including: Part 1, "General Provisions"; Part 3, "Licensing of Radioactive Material"; Part 4, "Standards for Protection Against Radiation"; Part 7, "Use of Radionuclides in the Healing Arts"; Part 10, "Notices, Instructions and Reports to Workers; Inspections"; and Part 17, "Transportation of Radioactive Material".

B. The Radiation Safety Officer shall maintain documentation of the training and experience for each person who uses radioactive materials under the supervision ofan authorized user.

7.C Revision 5 License No. Colo. 1012·0], Amendment No. 23 Page 4 of7


C. Each person who uses radioactive material under the supervision of an authorized user shall be supervised and receive instruction in accordance with the requirements of Section 7.10 and Section 10.3 of the Regulations.

D. The licensee shall not transfer possession and/or control of radioactive materials or items contaminated with radioactive material except: by transfer of waste to an authorized recipient; by transfer to a specifically licensed recipient; or, as provided otherwise by specific condition ofthis license pursuant to the requirements of Part 3, Section 3.22 of the Regulations.

E. Radioactive material authorized by Item 10 of this license shall be stored and used in a manner that will preclude possession or use by unauthorized personnel.

F. The licensee shall ensure that information listed in this license is correct and accurate. The licensee shall notify the Department in writing within ten (10) days whenever the information contained in Items 1 through 7 above is no longer current or determined to be incorrect.

G. The licensee may transport radioactive material or deliver radioactive material to a carrier for transport in accordance with the provisions of Part 17 of the Regulations and the requirements ofD.S. Department of Transportation (49 CFR).


13. Specific Radiation Safety Requirements:

A. Each sealed source authorized in Item 10 of this license or in Section 7.19 of the Regulations shall be tested for leakage and/or contamination in accordance with the requirements of Section 7.20.2 of the Regulations, and Part 4, Section 4.16 of the Regulations, at intervals not to exceed six (6) months.

B. In addition to the other requirements ofPart 7 of the Regulations, mobile medical service licensees shall conduct operations in accordance with Section 7.3.5 and 7.27 of the Regulations unless otherwise authorized in writing by the Department.

C. The licensee shall post the telephone number(s) of the Radiation Safety Officers and authorized users in the mobile coach for emergency notification.

D. An authorized user listed in condition 11 of this license shall be responsible for approving in writing the patient schedule prior to initiating scans and shall be responsible for the supervision of technologists operating under this license at that location.



14. Special License Requirements:

A. Installation, relocation, maintenance, repair, leak testing and initial survey of devices that contain radioactive material and replacement, and disposal of sealed sources that contain radioactive material that is used in devices shall be performed only by the manufacturer, or by other persons who are specifically authorized by the U.S. Nuclear Regulatory Commission or an Agreement State having jurisdiction over the possession and use of accelerator produced radioactive material.

B. The licensee is authorized to operate not more than 2 mobile unites) within the state of Colorado at anyone time.

C. Radioactive materials authorized by Conditions 10.A; 10.B; 10.C.iii, 10.D, and 10.E may be used and stored at the following location:

i. Rocky Mountain Cancer Center· Boulder 4715 Arapahoe Avenue, Boulder, Colorado 80303

D. Radioactive materials authorized by Conditions 1O.A through 1O.E. may be used and stored at the following locations:

i. Rocky Mountain Cancer Center - Colorado Springs 3027 North Circle Drive, Colorado Springs, Colorado 80909

ii. Rocky Mountain Cancer Center· Denver 1800 Williams Street, Denver, Colorado 80218

E. Radioactive materials authorized by Conditions 10.A; 10.B, IO.D, and 10.E may be used and stored in either of (2) PET mobile coaches at the following locations:

i. Rocky Mountain Cancer Center· Aurora 1700 South Potomac Street, Aurora, Colorado 80011

ii. Rocky Mountain Cancer Center - Lakewood 34 Van Gordon Street, Lakewood, Colorado 80228

iii. Rocky Mountain Cancer Center· Littleton 22 West Dry Creek Circle, Littleton, Colorado 80120

iv. Rocky Mountain Cancer Center· Thornton 8820 Huron Street, Thornton, Colorado 80260

v. Rocky Mountain Cancer Center· Denver 1800 Williams Street, Denver, Colorado 80218

vi. Rocky Mountain Cancer Center - Colorado Springs 3027 North Circle Drive, Colorado Springs, Colorado 80909

vii. Rocky Mountain Cancer Center- Longmont 1382 Tulip Street, Longmont, Colorado 80501

Vlll. Rocky Mountain Cancer Center- Lone Tree 10103 Ridge Gate Parkway, Lone Tree, Colorado 80124

7.C Revision 5 License No. Colo. 1012·0 I, Amendment No. 23 Page 6 of7


F. Unused patient doses and PET materials may also be stored for decay in the designated areas within any of the facilities that are listed in License Conditions 14.C through 14.E.

G. The licensee shall maintain a use log in the mobile coach indicating the authorized user, nuclear medicine technologist, the date, and location of use.

15. Licensee Commitments and Reference Documents:

The State of Colorado Rules and Regulations Pertaining to Radiation Control shall govern unless the licensee's statements, representations, and procedures contaihed in the application and correspondence are more restrictive than the Regulations. Except as specifically provided otherwise by this license, the licensee shall possess and use radioactive material described in Item 10 of this license in accordance with the statements, representations, arid procedures contained in: .

A. the application and attachments dated May 4, 2006; and

B. the license correspondence and attachments dated July 1, 2006; October 30, 2006; November 30,2006; December 14,2006; April 6, 2007; April 25, 2007; July 16,2008: August 20,2008; January 13, 2009; February 2,2009 (fax); February 9, 2009; March 6, 2009; September 21,2009 (email); October 1,2009; October 19,2009; April 26, 2010; June 23,2010; and July 6, 2010 (2 emails).

FOR THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENTDare;N /~2(}/O By: ~70~


, .

1. In accordance with BAMC Memo 40-72, USNRC License 42-01368-01, and Army Radioisotope Authorization 42-01-16 the BAMC Radiation Control Committee CRCC) issues the following Radioactive Material Permit:

a. Permit Number: NM-JG-l

b. Permit Expiration Date: Jun 2008

c. Permitted Individual: LTC Jess A. Graham

d. Permitted Activities: Authorized User (AU) lAW Title 10 CFR Part 35.

2. Permitted individual is responsible for complying with the requirements of Title 10, Code of Federal Regulations, USNRC License 42-01368-01, Army Radioisotope Authorization 42-01-16, BAMC Memo No. 40-72, established operating procedures, and the conditions of this permit.

3. The permitted individual is authorized to prescribe, prepare and administer radiopharmaceuticals for medical research, medical diagnosis, and therapy as specified below:

a. 10 CFR 35.100 Medical Use of Unsealed Byproduct Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is Not Required

b. 10 CFR 35.200 Medical Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive is Not Required

c. 10 CFR 35.300 Medical Use of Unsealed Byproduct Material for Which a Written Directive is Required

d. 10 CFR 35.500 Medical Use of Sealed Sources for Diagnosis

4. All administration of radiopharmaceuticals will be performed by the permitted individual, an individual supervised by the Chief, Nuclear Medicine Service lAW 35.27, or a student under the direct control of the permitted individual or a supervised individual.

5. Students administering radiopharmaceuticals shall be under the direct control of an individual authorized to administer radiopharmaceuticals. Direct control requires that the authorized individual observe and control every aspect of the student's actions. The authorized individual is responsible for the action and omission of the individual under their direct control.

6. The permitted individual shall immediately report unsafe conditions, loss of accountability of radioactive materials, or violations of operating procedures, regulatory requirements, or the conditions of this permit to the Radiation Safety Officer.

BAMC FORM 1056-E, AUG 94 PROPONENT:DEPTPVNTMED

7. The BAMC RCC determined the permitted individual met the training and experience requirement of the USNRC as evidenced by Amendment 29 to USNRC License No. 42-1911301, issued Apr 29, 2003, which listed the permitted individual as an Authorized User for the uses listed in 3.a thru 3.c above and for diagnostic uses of sealed sources.

APPROVED BY THE RCC electronically in: JUN 07 (RCC-0607-005):

CPT, MS Recorder, Radiation Control Committee

DATE: IJtllfJ ;;. Ot:)7

BAMe FORM I056-E, AUG 94 PROPONENT:DEPTPVNTMED

Enclosure 3

American Board of Radiology Certification and Preceptor Statement for Dr. Brent Tinnel

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INRcFO'UU13A U.S. NUCWR REGULATORY CO~SK)N (fQ..20(2) APPROVED BY OM;;.. NO. 3150-0120

TRAiNING AND EXPERIENCE AND PRECEPTOR STATEMENT EXPIRES: 10131/200S _.

PA~T ,-- TRAINING AND- EXPERIENCE

Note: Descriptions of training and. experience must contain sufficient detail to match the training and experience: :-:riteria in Ihe applicable regulations. -.

1. Name of Individ\Jal, Proposed Authorization (e.g., Radialion Safety Officer), and Applicable Training Requirements (e.g., 10 CFR 35.50)

~ eR.f\t A TinnaA I 01])

-2. For P~ysjcians. Podiatrists, Dentis~, Pharmacists - State or Territory \"itere Licensed

Vi(~\ttl<.\

3. CERTIFICATION

Specialty Board Category MontF.lnd Year Cft.rUfled

! .' Stop here when using Board CertlflcaUon to meot 10 CFR Part 35 training ab</ experiencfl require/~ients.

4. DIDACTIC OR CLASSROOM AND LABO~ATORYTP.AINING (option~ for Medical Physicist,,!

Description of Training LocaUon Clock Houra Dates Qf Training

J.(\~"'/11i\ \J\,,; III ~-.'1 SLloIoo\ IS\-.

t/I/O'2. . ~'J)/~ adiation Physics and Instrumentation ChDJ'<"~ I RIA~r~t'i~ On'~l 30

h-rW:~h T.r.~tII\oor~i~ ( :t

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5 '1/1/02 - ~/30ldo Radiation Protection ., rf'lelilH'\Sl., lZi..~i", D!\lo)\.)11

/)-t~,\tY'--n+. l"d~O'i) I IN .

J.r,OiI.~<.\ \.AYlllJt' 6l~ .51.. \'\00\ \t\l /i /0 2.- Y:;i).Jlo~

Mathematics Pertaining to the Use JY\l ~k,1\ (L I ~~ /,\1'\un O/'i\)\Cj-t 27and Measurement of Radioactivity . DLpM\i'<IIt'l'+, )i\~\"'~\;. l.tJ

. :tn~ilAn" Vf\iIJHb\i ~h~ ~

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YO 1. f1/1)1,- U.3\:l1 (.\Radiation Biology M'~L\nt , iL)iJ\~~ Of\u~

JAi'M~"t. 1"~lIfr",pdl!>I .1 N ~ ll\~iv-n" VAtlt'loo<.~ Sl."~\ It\

Co t It I1.Jl.- ~ 11\)\\)(.Chemistry of Byproduct Material for f'\)tt;ro. f4 ~~\'\~'n OC'Ul~Medical Use

D~ fW'rrt-II'\ \ ,~.r.. J\ .. nv~ ~ I

OTHER \) \l.~l~"'~.ro l'rt",\l"\o.nf ~ R",~'IlIl\t~ 't)I'M\c.1 I) -

200p\!J"M\{\~ 44\ "pp\iUA,"OO~. ~l~\-~n+. !.1\)iVC(l~ 1({ 102- ~[3Ofd:Jt) RI\ tM'~ ( ?C\ httl r) Uti \Iitf!.~ kr S'-'floo\ IS~ 2) 100

~o~ ",,4-~( '1 \'(\Qlll;nt . .!.t\\ilt-"~·I"'J :r.tJ RNRC FO M 313A (10-2002)

5b. SUPERVISED CLINICAL. CASE EXPERfENCE

Radlonuctide

P 31.

Co-(oQ

Type of Use No. of Cases IHame of Lo\~ation a«ld Dates and

Involving SUlpervlsing ,Corresponding ..clock Hours Personal IrndlviduaJ Materials Ucense of

Participatiorr Numbe~ Experience

NRC FORM 313A (10-2002)

) PAGE 2

--------------

U.S. NUCt.EAR REGULATORY COMMlS$loNNRC FORM313A (1o-@02) TRAINING AND EXPERIENCE AND PRECEf:'TOR STATEMENT (continued)

6. FORMAL TRAJNING (appfles to Medical Physicists and Therapy Phyelclans) Name of Oflanlatiollthat

Nameof Pr~and Approved the ProgRlmDegree, Area ofStudy Location wJUl (e.g., Accreditation CO\Incil

or CorrespondIng " Oates for Graduate MedIcal Education) Residency Program "u MateNrfafs be and Ule Applicable Rt-gulatlon

cen.. um r e. ., 10 CFR 35A90

R.(),~\"~~ O(\tlj\O~ J I

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l3~ D~ts7. -0" 7. RADIATION SAFETY OFFiCER - ONE·YEAR FUL....TNE WORK EXPERIENCE

DyES Completed 1.year of full-tineradlatlon Ufelly ~nce(tp areas identifte(Hn Item 58) under supervir.,:m

o NlA of theRSO for Ucense No.

8. MEDICAL PHYSICIST - ONE·YEAR FULL-TIME TRAININGlWORK EXPERIENCE

DyES Completed 1-year of full-time 1rainlfllJln thewapeutic radiological physics under the supervision of

DNIA who meefsrequnmenu forAufhorized Medfcal Physicists; and

DYES Completed 1·yearof fulJ-tlme wOf1( ~ (for areas identified In Item 58) for

DN/A modalityQea) under thesupelVisfon of who meet.,

reqUirements of Aufh~ed Medical Physlc:iillts for modality(ies).

9. SUPERVISING JNDMDUAL -IDENTIFICATION AND QUAUFICAnONS

The frainlng and experience Indicated above was obtalfle(l( under the supervision of (ifmore than one supervising individual Is needed to meet requirements In 10 CFR 35, provide the ,following information for each) ;

A. Name ofSupervisor B. SUpetMsor is; D... fI\ ...,\: L-y.-r "''' t..,,\)lM\,,"1 ,... . • t\01 f fl!t lj.( 41,,!«' 0'\ k!\'AA\!- tr\ ta W1thorized User 0 Authorized MedicalPhySlclst

f"\\I\I'1 0 iRadiation Safety Officer 0"Authorized Nuclear Pharmacist

C. Supervisor meets requirements 01 Part 35, Sectia:lh(s) '35· ~(). I 3t; ."1t.\() , 'be;.\rIO I ';'S.' t,Ol ''?-!\ltOt ~s..~

for medical uses in Part 35, Section(s) 1;,"5"\0 ~'~\i;~ ,l\\Y).plr1~.\' rl').) I ,5,1.\ll) j .fA}) .I ;,

D. Address E. Malerials Ucense Number

j"~I\fl(\cA \A(I.~t/:,\:t ~}I"lA\ CJl\tt',r

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j.,,)t(Mlrr!i.\,:>\ :tN ~~1.0"2~ SU \

PAGE a

.-, U.S. NUCLEAR REGULATORY COMMISSIONNRC FORM 3131.

(10-2002)

TRAINING AND EXPERiENCE AND PRECEPTOR STATEMENT (continued)

PART 11- PRECEPTOR STATEMEtn

Note: This padmust be campfeted by the Individuafs precePtor. Ifmore than Oln& preceptorIs necessary (0 docunnont experi9nce, obtain a separat~preceptorstatement (rom each. This part i:s not required to meet the training requirements In 10 CFR 35.590.

Item 10 musl be completed for NUClear Pharmac:lsts meeting the requii'emlents of 10 CFR Part 35, Subpart J. PreceptOl'$ do not have to compfete items 11e, 11b, or the certifyingslatements for other individuals meeting the requirements of 10 CFR Parf35, Subpart J.

171 YES 10. The Individual named In item 1has sstlsfacforially completed thetnlinlng reqUirements in

DN/A 10 CFR 35.980 and Is competenfto independenlly operate a nudear pharmacy.

fZJ YES 11a. l1lelndivldual named In Item 1 has satisfactOrily completed the Jf1K1ultements InPart 35, Section(s)

ON/A and Paragraph(S) ({) eF~ $oJ: ~O:

{1tVES .. 11b. . The individual named ~ Item 1. is competent to independently ft..Anction as an alihOlized

DN/A GI;S ey' for 0-1/ hulrit:::c n uses (orunies).

12. PRECEPTOR APPROVAL AND CERTIFICATION

D I certify the approval of Item 10 and certify I am an Aothorlz~ Nudeai' Pharmacist;

or

o I certify the approval of Iterns 11 a and 11b, and certify I am an AuthG'lz.ed Nuelear Pharmacist:

or to cFR ~A<roI certify the approvaJof Items 11aand 11b, and I J:»1'tify that I meetbreqUr8llnents of

or equivalentAgreement Slate requirements to be a preceptoraUlhorized uSer for the following uses (or units) of byprodUct material: heA!;';j c~c4-( Eh~~ ~.~

~Yc-d...yrlt.~y

A. Address B. M~la LJceose NLimber

I...JA-t.:rd flc-rf!) A-I2.1J"" UE-'b/~ q;;N'll:'I2 ~ I A:ji., ,.j 'f2rNc..cL-o a y ~v, c:.e <-.cit) " Ct:-e,v:;:ct,A Ave I\P. ,4. l:~l-".<J.:i'r:::y.J. ~ . ..)0) t;.:J

C. NAME Of PRECEPTOR (print cJi1Bt1yJ E. DATE

~ ;A. GA-N·' '/5706 PAGE 4

Enclosure 4

Letter from WRAIVlC approving Dr. Brent Tinnel as an Authorized User for NRC License 08-01738-02

DEPARTMENT OF THE ARMY WALTER REED ARMY MEDICAL CENTER WALTER REED HEALTH CARE SYSTEM

WASHINGTON, DC 20307-5001

Reply To Attention of

MCHL-HP 1 December 2009

MEMORANDUM FOR Chief, Radiation Oncology, Attn: Brent A. Tinnel, MAJ, MC, Department of Radiology, Walter Reed Army Medical Center, Washington, DC 20307-5001

SUBJECT: Authorization for Medical Use of Radioactive Material

1. J am pleased to infonn you that the Radiation Safety Committee reviewed your credentials on 12 November 2009 and approved your status as an authorized user, 10 CFR 35.400, at Walter Reed Army Medical Center on Nuclear Regulatory Commission (NRC) License 08-01738-02.

2. NRC Form 313A documentation of training and experience meet the qualifications under 10 CFR 35.490.

/flJJC~ MARK A. MELANSON COL,.MS Radiation Safety Officer

BETWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

[ FOR ARPB USE] INFORMATION FROM LTS - -- - - - _. - - _. -- -- - - - --

Program Code: 02120 Status Code: Pending Amendment Fee Category: 2B 3M 7C Exp. Date: Fee Comments: Decom Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION ATTACHED Applicant/Licensee: DEPARTMENT OF THE ARMY, MADIGAN ARMY MEDICAL CENTER

Received Date: 10/21/2010 Docket Number: 3003368

Mail Control Number: 573781 License Number: 46-02645-03

Action Type: Amendment

2. FEE ATTACHED

Amount:

Check No.:

3. COMMENTS

Signed: !!~~~v Date: /O-.J 9~ ~l?/t/

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered I I

1. Fee Category and Amount:

2. Correct Fee Paid. Application may be processed for:

Amendment:

Renewal:

License:

3. OTHER _

Signed:

Date:

of 1

From: Origin ID: OlMA (253) 966·4302 Ship Date: 210CT10 Mr PHILIP CAMPBEll ActWgt 1.0 lB MADIGAN ARMY MEDICAL CENTER CAD: 6921629/1NET3090 9040A FITZSIMMONS DR HEALTH PHYSICS Delivery Address Bar Code TACOMA, WA 98431

J103010181140225 11111111111 1111111111 11111111111111111111111111111111111111111111111111111111III111I1

SHIP TO: (253) 966-4302 BilL SENDER Ref # MR CAMPBELL HEALTH PHYSICS Invoice # PO#

NUCLEAR MATERIALS LICENSING BRANC US NRC REGION 4 Dept #,612 E LAMAR BLVD STE 400

ARLINGTON, TX 76011 FRI - 22 OCT A1

TRK# 102011 796367168242 STANDARD OVERNIGHT

76011 TX-US

XH FWHA DFW ~' t.

I •

.\ I~ ~

50AG1,126EfJ21'D

LI' 0 tj - ,~{)IO This is to acknowledge the receipt of your letter/application dated DATE

10 -/9 .,-Pt.; It>, and to inform you that the initial processing, which includes an administrative review, has been performed.

There were no administrative omissions. Your application will be assigned to a technical reviewer. Please note that the technical review may identify other omissions or require additional information.

D Please provide to this office within 30 days of your receipt of this card:

~

The action you requested is normally processed within -!LQ.... days.

D A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

/-0 ~ '7 viYour action has been assiqned Mail Control Number .,..O;::-..t.{...,;d::::.....L.1"",lj~_--:-__ When calling to inquire about this action, please refer to this mail control nu mber. You may call me at (817) 860-8103.

Sincerely,

(!IJ.-tt U4\,-;JrJttAAf/i>~~'fA--NRC FORM 532 (RIV) Licensing Assistant (10-2010)